The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further segmented as insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormone; whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Calcitonin and glucagon are considered in the recombinant peptides market. The recombinant glycosylated proteins segment is expected to witness the highest growth due to the increased demand for monoclonal antibodies in the treatment for cancer (oncology), autoimmune disorders, blood disorders, and infectious diseases. Oncology will be the fastest-growing segment and currently accounts for a 25% market share in the global market in 2013. Following monoclonal antibodies, biosimilars of insulin will be the fastest-growing products and are estimated to grow at a CAGR of 35.6% from 2013 to 2018. The growth is attributed to the rise in incidences of diabetes; ongoing patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of the biosimilars of insulin.

Other notable driving factors for the global market include increasing number of off-patented drugs, positive outcome in the ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders.

Market dynamics analysis has identified that rising budgetary pressures to reduce healthcare expenditures, increasing aging population, growing demand for cost-effective alternatives, rising incidences of various diseases, and conducive government initiatives are significant factors propelling the market in the forecast period (2013 to 2018). On the other hand, stringent regulatory environment, high manufacturing complexities and costs, and high-entry barriers are considered to hinder the market growth. Additionally, the different terminology and guidelines for biosimilars across regions will further burden the biosimilars industry. Generic versions of biologic drugs approved under the European Medical Agency (EMA) regulatory pathway and section 351K of the U.S. FDA are considered as biosimilars. In the U.S., biosimilars are also known as follow-on-proteins and have been approved under section 501(b), whereas in Canada, biosimilars are called Substituent Entry Biologics (SEB).

Geographic analysis reveals that Europe is the largest contributor to the global market. Asia-Pacific (China, India, and South Korea), North America (U.S.), and Latin America (Brazil) are poised to grow at high double-digit rates.

The global market is highly consolidated with the top three players, namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) accounting for approximately 90% of the market share. Other notable players in the market include Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and IntasBiopharmaceutical Ltd. (India).

From an insight perspective, this research report focuses on the qualitative data, market size, share, and growth of various segments and sub-segments, competitive landscape, and company profiles. The qualitative data covers various levels of industry analysis, such as market dynamics (drivers, restraints, opportunities, and threats), value chain, biosimilar pipeline analysis, porter’s five forces analysis, regulations, and reimbursement challenges across geographies. The report also offers market shares, sizes, and related growth of various segments of the industry. It also focuses on the emerging and high-growth segments of biosimilars (monoclonal antibodies and insulin), high-growth regions, countries, and the initiatives of their respective governments.

The grey area, while estimating the market size, is the different terminologies of biosimilars as well as different regulatory environments in different regions. The different terminologies considered for this study are Follow-on Proteins (U.S. and Japan), Subsequent Entry Biologics (Canada), Biosimilars (Europe and Australia), and Similar Biologics (Asia excluding Japan). North America and Europe have a stringent regulatory environment, whereas in comparison, Asia and RoW have a less stringent regulatory environment for approving biosimilars in the market.

The competitive landscape covers the growth strategies adopted by the industry players in the last three years. The company profiles comprise of the basic views on the key players in the biosimilars market and the product portfolios, developments, and strategies adopted to maintain and increase their market shares in the near future. The above-mentioned market research data, current market size, and forecast of future trends will help the key players and new entrants to make the necessary decisions regarding product offerings, geographic focus, change in strategic approach, R&D investments for innovations in products and technologies, and levels of output in order to remain successful.

Scope of the Report

The study covers the revenue market of recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides—the three major drug classes of the market. The sales revenue of each biosimilar drug was considered to estimate the global market. The market revenue for each therapeutic area was calculated based on the type of drugs used to treat a particular disease. The market share of the key players involved in manufacturing and commercializing biosimilar products was considered to estimate the market.

The following different terminologies of biosimilars are considered while estimating the market size:

Biosimilars Market

In North America, follow-on biologic products that were approved under section 501(b) of the regulatory pathway are considered while estimating the market size, while in Asia-Pacific; similar biologic products are considered to estimate the market size.

The sales revenue of both biogenerics and biobetters are not in the scope of this report. Biogenerics are the generic versions of biologic drugs that might not be the exact copy of biologics but a few variations are prevalent in these drugs with regards to efficiency, safety, and potency. Biobetters, on the other hand, are improvised versions of biologic drugs and are not similar or identical to biologic drugs in terms of efficacy, safety, and quality.

This research report categorizes the market into the following segments:

The global market is segmented on the basis of products, applications, and services. By product, the global biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further classified into insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone; whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Glucagon and calcitonin are considered under the recombinant peptides segment. The recombinant glycosylated proteins segment is the largest segment with a share of 40% of the global market in 2013. Of all the products, monoclonal antibodies will be the fastest-growing segment at an estimated CAGR of 41.9% from 2013 to 2018. Following this, insulin will be the second-fastest growing market from 2013 to 2018.The growth is attributed to the rise in incidences of diabetes; the ongoing patent expiration of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of biosimilars of insulin.

By application, the market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and others (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure). Oncology is the largest and fastest-growing segment of the global biosimilars market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyles. The global market will be worth $2.0 billion by 2018, growing at a CAGR of 20.1% during the forecast period (2013 to 2018). The major factors driving the growth of the market are the launch of new biosimilars (monoclonal antibodies, filgrastim, and follitropin); ongoing clinical research on potential pipeline products; patent expirations of various biologics such as Neupogen, Humira, and Lantus; and the increasing demand for first-wave biosimilar products such as somatropin, filgrastim, and erythropoietin.

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